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Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV

Sponsor
Chulalongkorn University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05006170
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
10.9
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection weighing from 6 to below 20 kg and to determine the dose of DTG that achieves adult target PK parameter(trough concentration; AUC24h)

Condition or Disease Intervention/Treatment Phase
  • Drug: DTG DT 20 mg
  • Drug: DTG DT 25 mg
 Phase 2

Detailed Description

After being informed about the study and potential risks, all legal guardians giving written informed consent will undergo check eligibility to enroll the study entry. Patients will be sort into 3 weight band groups 6 to below 10 kg, 10 to below 14 kg, and 14 to below 20 kg. ARTs will be switched to DTG dispersible tablet and ABC/3TC once daily will be prescribed according to weight band dosage. Total of 7 time point of blood sampling for plasma DTG concentrations will be measure at 7-14 day after medication switch. Patient will be follow up as schedule for total 24 week to assess safety, and efficacy of DTG dispersible tablet combine with ABC/3TC.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Each participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tabletEach participants will undergo ARTs medication switch to DTG dispersible tablet, and ABC/3TC dispersible tablet
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics, Safety, and Efficacy of Dolutegravir Dispersible Tablets in Young Children Living With HIV
Actual Study Start Date :
Aug 3, 2021
Anticipated Primary Completion Date :
Feb 28, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 6 to below 10 kg weight band

Children with perinatal HIV infection whose weight from 6 kg to below 10 kg

Drug: DTG DT 20 mg
Give 2 tabs of MYLTEGA DT (10mg) PO once daily
Other Names:
  • MYLTEGA Dispersible Tablet

    		•
    Experimental: 10 to below 14 kg weight band

    Children with perinatal HIV infection whose weight from 10 kg to below 14 kg

    Drug: DTG DT 20 mg
    Give 2 tabs of MYLTEGA DT (10mg) PO once daily
    Other Names:
  • MYLTEGA Dispersible Tablet

    		•
    Experimental: 14 to below 20 kg weight band

    Children with perinatal HIV infection whose weight from 14 kg to below 20 kg

    Drug: DTG DT 25 mg
    Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily
    Other Names:
  • MYLTEGA DT Dispersible Tablet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Steady-state pharmacokinetics of DTG dispersible tablets in children with HIV infection [At 7-14 day after started on DTG]

      Trough plasma DTG concentration and DTG exposure (AUC24h)

    Secondary Outcome Measures

    1. Serious adverse event incidence [24 week after medication switched]

      Incidence of grade 3 and 4 adverse events in use of DTG for HIV treatment in

    2. Antiretroviral activity of dolutegravir dispersible tablets combined with two standard background therapies [24 week after medication switched]

      HIV VL <40 copies/mL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Months to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children living with HIV weighing 6 to below 20 kg

    • Naïve to integrase inhibitors

    Exclusion criteria:

    • Currently active opportunistic infection

    • Liver dysfunction (SGPT below 100 IU/mL)

    • Renal dysfunction (GFR below 60 mL/min)

    • Currently using medication that interacts with DTG

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Infectious disease, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University Bangkok Thailand 10330

    Sponsors and Collaborators

    • Chulalongkorn University

    Investigators

    • Principal Investigator: Athiporn Premgamone, MD, Chulalongkorn University
    • Principal Investigator: Thanyawee Puthanakit, MD, Chulalongkorn University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chulalongkorn University
    ClinicalTrials.gov Identifier:
    NCT05006170
    Other Study ID Numbers:
    • DTGkids
    First Posted:
    Aug 16, 2021
    Last Update Posted:
    Nov 23, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Chulalongkorn University
    dolutegravir dispersible tablet
    pharmacokinetics
    weight below 20 kg
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Nov 23, 2021